Devices and methods for fastening tissue layers

ABSTRACT

Endoscopic devices and methods used for fastening multiple tissue layers, such as, for example, an endoscopic fundoplication procedure, are disclosed. The device may include, for example, an elongated tubular member having a proximal end for extending outside of the body and a distal end for positioning proximate the multiple tissue layers, a grasper configured for positioning proximate the distal end of the tubular member and for grasping at least one of the multiple tissue layers, a device coupled to the distal end of the tubular member for folding the multiple tissue layers together, a tissue fastener configured to be inserted into the tissue layers to hold the tissue layers together, and a fastener head for inserting the tissue fastener into the tissue layers.

This is a continuation of application Ser. No. 11/471,513, filed Jun.21, 2006, now U.S. Pat. No. 7,837,698 which is a continuation ofapplication Ser. No. 10/230,682, filed Aug. 29, 2002, now U.S. Pat. No.7,083,630, both of which are incorporated herein by reference.

CROSS-REFERENCE TO RELATED APPLICATION

This application relates to commonly assigned U.S. application Ser. No.10/230,672 of Robert DeVries et al. (Application Publication No.US-2004-0044364-A1), filed on Aug. 29, 2002, and entitled “TISSUEFASTENERS AND RELATED DEPLOYMENT SYSTEMS AND METHODS.” This applicationalso relates to commonly assigned U.S. application Ser. No. 09/920,809of Yem Chin, filed on Aug. 3, 2001, now U.S. Pat. No. 6,749,601, andentitled “PROTECTIVE SLEEVE FOR AN ENDOSCOPIC INSTRUMENT AND RELATEDMETHOD OF USE.” The complete disclosures of these applications areincorporated by reference herein.

DESCRIPTION OF THE INVENTION

1. Field of the Invention

The present invention relates to endoscopic devices and related methods.In particular, the present invention relates to endoscopic devices andmethods used in, for example, a tissue fundoplication procedure fortreatment of Gastroesophageal Reflux Disease (GERD).

2. Background of the Invention

Gastroesophageal reflux occurs when stomach acid enters the esophagus.This reflux of acid into the esophagus occurs naturally in healthyindividuals, but also may become a pathological condition in others.Effects from gastroesophageal reflux range from mild to severe. Mildeffects include heartburn, a burning sensation experienced behind thebreastbone. More severe effects include a variety of complications, suchas esophageal erosion, esophageal ulcers, esophageal stricture, abnormalepithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration.These various clinical conditions and changes in tissue structure thatresult from reflux of stomach acid into the esophagus are referred togenerally as Gastroesophageal Reflux Disease (GERD).

Many mechanisms contribute to prevent gastroesophageal reflux in healthyindividuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). With reference to FIG. 1, the LES 2 is aring of smooth muscle and increased annular thickness existing inapproximately the last four centimeters of the esophagus. In its restingstate, the LES creates a region of high pressure (approximately 15-30 mmHg above intragastric pressure) at the opening of the esophagus 3 intothe stomach 7. This pressure essentially closes the esophagus 3 so thatcontents of the stomach cannot pass back into the esophagus 3. The LES 2opens in response to swallowing and peristaltic motion in the esophagus,allowing food to pass into the stomach. After opening, however, aproperly functioning LES 2 should return to the resting, or closedstate. Transient relaxations of the LES 2 do occur in healthyindividuals, typically resulting in occasional bouts of heartburn.

The physical interaction occurring between the gastric fundus 5 and theesophagus 3 also prevents gastroesophageal reflux. The gastric fundus 5is a lobe of the stomach situated at the top of the stomach 7 distal tothe esophagus 3. In asymptomatic individuals, the fundus 5 pressesagainst the opening of the esophagus 3 when the stomach 7 is full offood and/or gas. This effectively closes off the esophageal opening tothe stomach 7 and helps to prevent acid reflux back into the esophagus3. More specifically, as the food bolus is immersed in gastric acid, itreleases gas which causes the fundus 5 of the stomach 7 to expand andthereby exert pressure on the distal esophagus 3 causing it to collapse.The collapse of the esophagus lumen reduces the space for the stomachacid to splash past the closed esophagus lumen and thereby protect theproximal esophagus from its destructive contact.

In individuals with GERD, the LES 2 functions abnormally, either due toan increase in transient LES relaxations, decreased muscle tone of theLES 2 during resting, or an inability of the esophageal tissue to resistinjury or repair itself after injury. These conditions often areexacerbated by overeating, intake of caffeine, chocolate or fatty foods,smoking, and/or hiatal hernia. Avoiding these exacerbating mechanismshelps curb the negative side effects associated with GERD, but does notchange the underlying disease mechanism.

A surgical procedure, known generally as fundoplication, has beendeveloped to prevent acid reflux in patients whose normal LESfunctioning has been impaired, either as a result of GERD or otheradverse effects. This procedure involves bringing the fundus wall 6 intocloser proximity of the esophageal wall 4 to help close off theesophageal opening into the stomach 7, as shown in FIG. 2.Traditionally, this procedure has been performed as an open surgery, butalso has been performed laparoscopically.

As with any surgery, the attendant risks are great. Due to relativelylarge incisions necessary in the performance of open surgery, relativelylarge amount of blood is lost, the risk of infection increases, and thepotential for post-operative hernias is high. Further, the relativelylarge incisions necessary in the performance of open surgery requireextended recovery times for the incision to heal.

A laparoscopic procedure may involve performing laparotomies for trocarports (penetrations of the abdominal wall), percutaneous endoscopicgastronomies (incisions through the skin into the stomach), and theinstallation of ports through which, for example, a stapler, anendoscope, and an esophageal manipulator (invagination device) areinserted. Under view of the endoscope, the esophageal manipulator isused to pull the interior of the esophagus 3 into the stomach 7. Whenthe esophagus is in position, with the fundus 5 of the stomach plicated,the stapler is moved into position around the lower end of the esophagusand the plicated fundus is stapled to the esophagus 3. The process maybe repeated at different axial and rotary positions until the desiredfundoplication is achieved. This procedure is still relatively invasiverequiring incisions through the stomach, which has a risk of infection.The location of the incision in the abdominal wall presents a risk ofother negative effects, such as sepsis, which can be caused by leakageof septic fluid contained in the stomach.

SUMMARY OF THE INVENTION

Therefore, it is accordingly an object of the present invention toprovide less invasive devices and methods for performing thefundoplication procedure. This is achieved by utilizing fundoplicationdevices which can be endoluminally delivered through the esophagus,thereby eliminating the need for highly invasive, physiologicallyinsulting surgical procedures.

To attain the advantages and in accordance with the purpose of theinvention, as embodied and broadly described herein, one aspect of theinvention provides a system for fastening multiple tissue layers of abody. The system may include various components, including, for example,an elongated tubular member having a proximal end for extending outsideof the body and a distal end for positioning proximate the multipletissue layers, a grasper configured for positioning proximate the distalend of the tubular member and for grasping at least one of the multipletissue layers, a device coupled to the distal end of the tubular memberfor folding the multiple tissue layers together, a tissue fastenerconfigured to be inserted into the tissue layers to hold the tissuelayers together, and a fastener head for inserting the tissue fastenerinto the tissue layers. According to another aspect, the inventionincludes related methods of using these various components to insert atissue fastener and fasten multiple tissue layers together.

According to a further aspect, the invention includes a device forfolding together multiple tissue layers of a body. The device mayinclude an elongated tube having a proximal end for extending outside ofthe body and a distal end for positioning proximate the multiple tissuelayers, an actuation handle coupled to the proximal end of the tube, anda distal body coupled to the distal end of the tube, the distal bodyincluding a fixed portion and a folding arm pivotally connected to thefixed portion, and an elongate member extending through the tube toconnect the handle and the folding arm. Rotation of at least a portionof the handle causes translation of the elongate member to pivot thefolding arm from a closed position to an open position. According toanother aspect, the invention includes related methods of using such adevice to fold multiple tissue layers together.

According to yet another aspect, the invention includes a device forprotecting a lumen of a body during an endoluminal delivery of asurgical device. The device may include a substantially cylindrical,inflatable balloon defining an internal space along at least a portionof a length of the balloon for accepting the surgical device, a handlehaving a port for connection to a source of inflating fluid, and ahollow, elongate tube connecting the port to the balloon. According toanother aspect, the invention includes related methods of using aprotection device for protecting a body lumen during insertion of asurgical device.

According to an even further aspect, the invention includes a device forgrasping tissue of a body. The device may include an elongated tubehaving a proximal end for extending outside of the body and a distal endfor positioning proximate tissue, an actuation handle coupled to theproximal end of the tube and including a connection for connecting to avacuum source, and a distal body coupled to the distal end of the tubeand including a distal head defining an opening in fluid communicationwith the vacuum source and jaws for grasping tissue received in theopening by suction. According to another aspect, the invention includesrelated methods of using the grasping device for grasping tissue.

According to a still further aspect, the invention includes a device fordelivering a tissue fastener to multiple tissue layers. The device mayinclude an elongated tube having a proximal end for extending outside ofthe body and a distal end for positioning proximate the multiple tissuelayers, a head coupled to the distal end of the tube and having a slotto hold a tissue fastener, and a needle configured to extend through alumen of the tube to and through a curved groove in the head leading tothe slot. According to another aspect, the invention includes relatedmethods of using the delivery device for delivering a tissue fastener toand into the tissue layers.

According to another aspect, the invention includes a method offastening multiple tissue layers together that includes the steps ofinserting an elongated tubular member into a body passage so that adistal end of the tubular member is proximate the tissue layers,positioning a grasper proximate the distal end of the tubular member,grasping at least one of the multiple tissue layers, folding themultiple tissue layers together by a distal body of the tubular member,and inserting a tissue fastener into the tissue layers to hold thetissue layers together.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

In the drawings:

FIG. 1 is a cross-sectional view of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach;

FIG. 2 is a cross-sectional view of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach, after a fundoplication procedure is performed;

FIG. 3 is a perspective view of the gastrointestinal tract in the regionof the lower esophageal sphincter (LES) and the fundus of the stomach,showing the cross-sectional view of the A-A′ plane of FIG. 2 after afundoplication procedure is performed;

FIG. 4 is a perspective view of an A-frame device, according to anembodiment of the present invention;

FIGS. 5-7 are side, top, and front views of an A-frame head,respectively, with a folding arm in a closed position, according to anembodiment of the present invention;

FIG. 8 is a perspective view of the A-frame head, shown in FIGS. 5-7,with the folding arm in an open position;

FIG. 9 is an enlarged view of section B of FIG. 8;

FIGS. 10-11 are schematics illustrating the opening and closingoperations of the foldable arm of an A-frame head, according to anembodiment of the present invention;

FIG. 12 is perspective views of a downtube, showing different assemblystages, according to an embodiment of the present invention;

FIG. 13 is a perspective view of a distal adapter, according to anembodiment of the present invention;

FIG. 14 is a perspective view of a proximal adapter, according to anembodiment of the present invention;

FIG. 15 is an exploded perspective view of an A-frame handle, accordingto an embodiment of the present invention, showing the components of theA-frame handle;

FIG. 16 is a side view of an A-frame handle, according to anotherembodiment of the present invention, with portions removed to exposecomponents;

FIG. 17 is a partial top view of an A-frame handle, with portionsremoved to show certain components;

FIGS. 18-19 are side and end views of an A-frame handle, shown in FIG.16, without the actuation device in place;

FIG. 20 is a perspective view of a protection device, according to anembodiment of the present invention;

FIG. 21 is a side view of a protection device, according to anotherembodiment of the present invention;

FIG. 22A is a perspective view of a protection device, according tostill another embodiment of the present invention;

FIG. 22B is a cross-sectional view of the protection device shown inFIG. 22B along the X-X′ plane of FIG. 22B;

FIG. 23A is a perspective view of a protection device, according tostill another embodiment of the present invention;

FIG. 23B is a cross-sectional view of the protection device shown inFIG. 23A along the Y-Y′ plane of FIG. 23A;

FIG. 24 is a perspective view of a suction grasper, according to anembodiment of the present invention;

FIG. 25 is a perspective view of an A-frame device, shown in FIG. 4,with the suction grasper shown in FIG. 24;

FIGS. 26-27 are top and bottom views, respectively, of a grasper head,according to an embodiment of the present invention, showing variouscomponents;

FIGS. 27A-D are schematic illustration of a connection method between anoperating cable and a pair of jaws, according to an embodiment of thepresent invention.

FIG. 28 is various views of a grasper handle, according to an embodimentof the present invention;

FIG. 29 is a side view of the grasper handle shown in FIG. 28;

FIG. 30 is another side view of the grasper handle shown in FIG. 28;

FIG. 31 is an exploded perspective view of the grasper handle shown inFIG. 28, showing various components of the grasper handle;

FIG. 32 is perspective views of a fastener delivery system showingvarious components of the system, according to an embodiment of thepresent invention;

FIG. 33 is a side view of a needle and a pusher, according to anembodiment of the present invention;

FIG. 34 is detailed views of a two-piece head of the fastener deliverysystem shown in FIG. 32;

FIG. 35 is side views of a main body, a needle driver, and a pusherdriver of a delivery system handle, according to an embodiment of thepresent invention;

FIG. 36 is a side view of a delivery system handle, according to anembodiment of the present invention;

FIGS. 37A-37B are exemplary embodiments of double T-fasteners, accordingto various embodiments of the present invention;

FIGS. 38A-38C are exemplary embodiments of adjustable button fasteners,according to various embodiments of the present invention;

FIGS. 39-45 are schematic illustrations of an endoscopic tissuefastening method, according to an embodiment of the present invention;

FIG. 46 is a schematic illustration of a method of fastening multipletissue layers, according to an embodiment of the present invention;

FIG. 47 is a perspective view of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach, after a fundoplication procedure is performed with doubleT-fasteners;

FIGS. 48-49 are schematic illustrations of a method of fasteningmultiple tissue layers, according to another embodiment of the presentinvention; and

FIGS. 50-52 are perspective views of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach, after a fundoplication procedure is performed with variousembodiments of the tissue fasteners shown in FIGS. 38A, 38B, and 38C,respectively.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

A newly developed form of fundoplication, referred to as endoscopicfundoplication, is an endoluminal procedure in which the fundus wall 6is folded back onto the esophagus wall 4 and wraps around the esophagus3, as shown in FIGS. 2 and 3. The tissue fold 1 formed between theesophagus 3 and the fundus 5 then is secured by a suitable fasteningmeans, such as, for example, a plurality of double T-fasteners 200,shown in FIG. 3. The endoscopic fundoplication may be performed as anendoluminal procedure in which insertion of required medical instrumentsoccurs through the esophagus 3. Such a procedure has the benefits ofbeing less invasive, quicker, and less expensive as compared to previoustechniques.

An endoluminal system used in, for example, a fundoplication procedure,according to an embodiment of the present invention, may include anumber of individual components. These components may include an A-framedevice, a protection device, an invagination device, a fastener deliverysystem, and at least one tissue fastener, each of which will bedescribed separately in the following subsections.

A-Frame Device

FIG. 4 shows an A-frame device 10 according to an embodiment of thepresent invention. The A-frame device 10 includes an A-frame head 20, anA-frame handle 30, and a downtube 15. The A-frame head 20 and theA-frame handle 30 are each connected to the downtube 15 via a distaladapter 12 and a proximal adapter, respectively, both of which will beshown and described further herein. The downtube 15 can extend fromoutside of a body to a site deep within the body, and is sufficientlyflexible to traverse through tortuous paths within a body, such as, forexample, to the gastroesophageal junction site. The downtube 15 containsa plurality of lumens, also to be described further herein, that aredesigned to encompass various operating devices and related activationmeans, such as, cables and rods, for manipulating the operating devices.

FIGS. 5-7 show side, top, and front views of the A-frame head 20 with afolding arm 25 in a contracted or closed position, according to anembodiment of the present invention. The A-frame head 20 is a relativelyshort cylindrical tube having a main body 21 and a folding arm 25. TheA-frame head 20 may be made of metal, such as stainless steel andtitanium, polymers, ceramics, or any combination thereof. The A-framehead 20 has a tapered distal end portion to permit easier passagethrough a narrow lumen of the body, such as, for example,cricopharyngeal area. The proximal end of the folding arm 25 (i.e., theend-most proximal part when the arm 25 is in the open position) isrotatably coupled to a pivot member 27 disposed in the distal endportion of the main body 21. The pivot member 27 may be a pin or anyother suitable mechanism. The outer profile of the folding arm 25 ispreferably configured such that, in the closed position, the folding arm25 is substantially flush with an outer surface of the main body 21, andforms a generally cylindrical outer profile with the main body 21.

FIGS. 8 and 9 show the A-frame head 20 with the folding arm 25 in anextended or open position, according to an embodiment of the presentinvention. In the open position, the folding arm 25 rotatably extends toreceive multiple tissue layers to be folded between the folding arm 25and the main body 21. The folding arm 25 has a generally U-shapedconfiguration defining an opening 26 or a slot along its length topermit passage of fastening devices and fastening members, once themultiple tissue layers are folded together and ready to be fastened. Onthe inner surface of the folding arm 25, a friction-enhancing member,such as, for example, a plurality of teeth 28, are formed to tightlyhold the tissue layers during the folding and holding operations. Inaddition, at least a portion of the A-frame head 20 may be coated with apolymer or elastomer material to provide a softer contact between thetissue and the A-frame head 20 and to enhance the grip of the A-framehead 20 on the tissue.

With reference to FIGS. 10 and 11, as well as FIGS. 5-9, the opening andclosing operations of the foldable arm 25 of the A-frame head 20 aredescribed herein, according to an embodiment of the present invention.In this embodiment, the opening and closing operations of the foldingarm 25 is manipulated by a pair of flexible cables 22 or wires that canbe actuated by a suitable mechanism in the A-frame handle 30, which willbe described further herein. Each of the pair of cables 22 extends fromthe A-frame handle 30 to the A-frame head 20 through cable lumens formedin the downtube 15, also to be shown and described further herein. Asshown in FIGS. 5-9, each cable 22 passes through one of two cable paths22 a, 22 b formed along the length of the each side 21 a, 21 b of themain body 21. The cable 22 then passes through a cable opening 24 in thefolding arm 25, follows around a cable groove 22 c formed along thedistal end portion of the foldable arm 25, and passes back into theother of the two cable paths 22 a, 22 b in the main body 21. The cable22 then extends back to the A-frame handle 30 through the cable lumen ofthe downtube 15, thereby forming a loop. Preferably, the cable paths 22a, 22 b formed in each side of the main body 21 are reinforced lumens,so that the cable can freely slide along the cable paths 22 a, 22 b.

As can be best seen from FIGS. 10 and 11, an anchoring member, such as,for example, a rigid ball 23, is fixedly attached to the loop cable 22in the cable groove portion of the folding arm 25. Preferably, a portionof the cable groove 22 c forms a ball socket 23 a in which the rigidball 23 is held in place during the opening and closing operation. Inoperation, by slidably displacing the cable 22 in the directionsindicated by the arrows in FIGS. 10 and 11, the folding arm 25 is openedand closed, respectively. More specifically, sliding motion of the cable22 in the counterclockwise direction exerts a torque on the distal edgeportion of the folding arm 25 and causes the folding arm 25 to rotatablyopen with respect to the pivot member 27. On the other hand, slidingmotion of the wire 22 in the clockwise direction exerts an inwardlydirected torque on the folding arm 25 and causes the folding arm toclose. Although the operation of the foldable arm 25 is described withrespect to an exemplary embodiment shown in FIGS. 5-11, it should beunderstood that any other suitable mechanisms known in the art can bealternatively used.

FIG. 12 shows various assembly stages of the multi-layered downtube 15,according to an embodiment of the present invention. As shown in the topof the figure, the downtube 15 includes a generally cylindricalpolymeric tube 16 reinforced with a flexible polymer braid material. Adistal adapter 12 is attached to the distal end of the tube 16 forconnection with the A-frame head 20. The attachment between the distaladapter 12 and the tube 16 may be achieved through an interference,friction fit. FIG. 13 shows the distal adapter 12 in detail. The distaladapter 12 is a relatively short rigid piece filled with a polymericmaterial and has a plurality of lumens 11 a, 11 b, 13, 14 providingpassages for the various operating devices and related cables. In thisembodiment, the plurality of lumens include four coil lumens 11 a, 11 bfor the A-frame head operating cables 22, a scope lumen 13 for anendoscope, and a main working channel 14 having an arcuate configurationand providing passages for various operating devices, such as, forexample, a grasper and a tissue fastener delivery system. Preferably, atleast the main working channel 14 and the scope lumen 13 are reinforcedwith a polymeric braid material. The outer surface of the distal adapter12 includes a plurality of openings 19 through which the polymericfilling material makes contact with the inner surface of the cylindricaltube 16 to enhance the adhesion between the cylindrical tube 16 and thedistal adapter 12. The outer surface of the distal adapter 12 includes amarking 19 a for indicating and aligning the main working channel 14with the A-frame head 20 during assembly. The distal end of the adapter12 includes a plurality of holes 9 for connection with the A-frame head20. In some of the holes, similar to the openings 19 in the proximal endof the adapter 12, the polymeric filling material in the adapter 12makes contact with the inner surface of the distal end portion of theA-frame head 20 to enhance the adhesion between the A-frame head 20 andthe distal adapter 12. On the other hand, some of the holes are used toconnect the A-frame head 20 and the distal adapter 12 by screws.

As shown in FIG. 12, once the distal adapter 12 is attached to thedistal end of the downtube 15, the cylindrical tube 16 is covered with alayer of polymeric braid material 17. After the A-frame head 20 isconnected to the downtube 15 via the distal adapter 20, the downtube 15is then coated with a polymeric material, such as PVC, as shown in thebottom of FIG. 12.

FIG. 14 shows the proximal adapter 29 used to connect the proximal endof the downtube 15 to the A-frame handle 30. The proximal adapter 29preferably is a relatively short, rigid piece that includes a largelumen 31 providing passages for the various operating devices andrelated cables. The proximal adapter 29 also includes a marking 32 forindicating and aligning the main working channel portion of the largelumen 31 with the A-frame handle 30 during assembly.

FIG. 15 is an exploded view, showing individual components of theA-frame handle 30, according to an embodiment of the present invention.The A-frame handle 30 includes a handle cover 33, a front transitionpiece 34 having a bearing plate 36 and a funnel 35, a plurality ofsealing members 37, an actuation device 38, a handle knob 45 with anactuation gear 46 on its inside surface, and a backing plate 47. FIG. 15also shows a plurality of pins, screws, or other like means forattaching these various components together. FIG. 16 shows an A-framehandle 30, according to another embodiment of the present invention.This embodiment is substantially identical to the embodiment shown inFIG. 15 except that: the funnel 35 and the plurality of sealing members37 are replaced with a sealing plate 48 on a backing plate 47 a andsealed channels 52, 53, which will be described further herein.

The handle cover 33 is preferably is one-piece polymer and encompassesall of the components of the handle 30, except the knob 45. The fronttransition piece 34 snaps into the cover 33 in the most distal portionof cover 33 and functions as a spacer for mechanical connection betweenthe A-frame head 20 and the handle. The funnel 35 is configured to fitinside the transition piece 34 and provides means for sealing the devicefrom the gases and fluids of the stomach. The bearing plate 36 coversthe transition piece 36. The plurality of sealing members 37 providesadditional and redundant sealing means for the gases and fluids of thestomach. Once all components except the knob 45 are assembled into thecover 33, the cover 33 is inserted into the distal end of the knob 45and the backing plate 47 is fixedly attached to the proximal end face ofthe cover 33 through the knob 45.

As shown in FIGS. 16 and 17, the actuation device 38 includes a pair ofclamp drives 44 disposed on opposite sides of a main body 49. Each ofthe clamp drives 44 includes a gear shaft 39 having a threaded portion40 on its distal portion, and a gear 41 on its proximal portion forengagement with the actuation gear 46 of the handle knob 45. Thethreaded portion 40 on the gear shaft 39 is inserted into a threadedcylindrical follower 42, and a yoke 43 having a pair of pinions 43 a, 43b is fixedly attached on the outer surface of the follower 42, such thatthe yoke 43 can float axially along the threaded portion 40 of the gearshaft 39.

As shown in FIG. 17, the A-frame head operating cables 22 are connectedto the pair of pinions 43 a, 43 b of the yoke 43. One end of each cable22 is connected to each of the pinions of the same yoke 43 shown in FIG.17. For example, the two cables 22 connected to the top yoke 43 are thecables 22 passing through the upper cable path 22 a in each side of theA-frame head 20, while the two cables 22 connected to the bottom yoke 43are the cables 22 passing through the lower cable path 22 b. Thus, inoperation, when the handle knob 45 is rotated, the actuation gear 46causes the gear shafts 39 to rotate in the same direction. Since theclamp drives 44 are disposed in opposite side of each other, therotation of the handle knob 45 causes each of the yokes 43 to move inopposite directions to each other. The relative movement of the top andbottom yokes 43 drives the opening and closing operations of the foldingarm 25 of the A-frame head 20.

FIGS. 18 and 19 show the A-frame handle 30 without the actuation device38 in place. The A-frame handle 30 includes a channel 52 for anendoscope and a channel 53 for other various operating devices. Thesechannels 52, 53 are accommodated in the main body 49 of the actuationdevice 38. Once the main body 49 containing the cable actuation deviceis installed, the backing plate 47 a having sealing members 54 for thechannels 52, 53 are attached at the proximal ends of the channels. Thesealing members 54 may extend into channels 52, 53 to such a depth as toobviate the need for the plurality of sealing members 37 shown in FIG.15.

Protection Device

FIG. 20 shows a protection device 60, according to an embodiment of thepresent invention. The protection device 60 is used to protect theesophageal wall 4 from possible damage during insertion of the A-framedevice 10 into the esophagus 3 by covering the distal end portion of theA-frame device 10. The device 60 includes a protective sleeve 62 and ahandle 64 having a length sufficient to extend outside of a body. Thesleeve 62 is generally cylindrical in shape with tapered distal end andis made of materials having sufficient strength to resist tearing fromsharp edges or protrusions from the endoscopic instrument it covers. Thesleeve 62 also has sufficient flexibility and deformability, so that itcan be pulled back through the working channel of the A-frame device 10once the A-frame device 10 is in position in the stomach.

Preferably, the sleeve 62 is made of a polymer mesh (e.g.,tetrahydrophurane) reinforced with polyurethane coating. However, anyother suitable materials known in the art, including mylar, nylon, PET,polyethylene, or vinyl, can also be utilized. In addition, the surfaceof sleeve 62 can be coated with a hydrogel or any other lubricatingmaterial known in the art to allow easier passage through the esophagus3 or other body lumens. The sheath 62 also has an opening 63 on itsdistal end to permit passage of an endoscope for viewing. The sleeve 62may also be made of a translucent material for the endoscope to view andposition the A-frame device 10 more precisely. The handle 64 hassufficient flexibility to pass through the esophagus. The handle 64 hasa proximal holder 64′, both of which have a sufficient, small diameterto insert within the working channel of the A-frame device 10.Preferably, the protection device 60 is back-loaded into the A-framedevice 10, i.e., loaded into the distal end of the A-frame device 10.Handle 64 has FIG. 21 shows an alternative embodiment of a sleeve 62 a.The sleeve 62 a has a tapered distal portion slightly longer than theone shown in FIG. 20, and may be made of a more flexible thin membranematerial. Typical thickness of a sleeve 62, 62 a may range from 0.005inch to 0.010 inch with a nominal thickness of 0.010 inch.

FIGS. 22A and 22B show a protection device 66, according to stillanother embodiment of the present invention. The protection device 66includes a generally hollow, cylindrical, inflatable balloon 67 withtapered distal end, and a fluid-supplying member 69 disposed at itsproximal end. The fluid-supplying member 69 may also include aconnector, such as, for example, a luer-lock type connector, forconnecting to a source of air or other bio-compatible fluid (e.g.,saline solution) to fill the balloon 67. Prior to insertion of theA-frame device 10, the fluid-supplying member 69 supplies thebio-compatible fluid to the balloon 67 through a fluid-supply tube 68. Adistal portion of the balloon 67 has a port 70 in fluid communicationwith the tube 68 for receiving air and inflating the balloon 67. Duringthe insertion, the inflated balloon 67 predilates the esophagus beforethe A-frame head 20 makes contact with the esophageal tissue and therebyprotects the esophageal tissue from potential damages caused by thecontact between the A-frame head 20 and the tissue. The cylindricalopening 65 of the balloon 67 provides a passage for an endoscope forviewing. Once the balloon 67 is fully inflated, the balloon 67 seals thegap between the balloon 67 and the endoscope during the insertion.

The fluid-supply tube 68 may also be used as a handle for removing theprotection device 66. After the balloon 67 is deflated, the tube 68 ispulled to withdraw the balloon 67. The balloon 67 having sufficientflexibility becomes inverted and fit through the working channel of theA-frame device 10. Other suitable devices, such as a stylet or aflexible cable, can be used with, or in place of, the fluid-supply tube68 for the insertion/removal operations.

FIGS. 23A and 23B show a protection device 78, according to stillanother embodiment of the present invention. Similar to the protectiondevice 66 shown in FIGS. 22A-22B, the device 78 includes a generallyhollow, cylindrical, inflatable balloon 75 with taped distal end portion74. In this embodiment, the distal end portion 74 of the balloon 75 hasa thicker inflated portion 76 than the rest of the balloon 75, providinga bumper in front of the A-frame head 20. The inside surface of thedistal end portion 74 includes a fluid-supply port 77 in fluidcommunication with a fluid-supply tube 68 for receiving air andinflating the balloon 75. When the balloon 75 is inflated and anendoscope is inserted through the opening 65, the balloon 75 can beprovided with means for sealing the gap between the balloon 75 and theendoscope during the insertion.

Other various embodiments of a protection device, such as theembodiments described in the commonly assigned U.S. application Ser. No.09/920,809 of Yem Chin, filed on Aug. 3, 2001, the disclosure of whichis hereby incorporated by reference, may alternatively be utilized.

Invagination Device

FIG. 24 shows an invagination device, according to an embodiment of thepresent invention. The invagination device shown in the figure is asuction grasper 80 that uses an air suction mechanism to grasp tissue.The grasper 80 includes a grasper head 85, a coil lumen 87, and agrasper handle 90, as its main components. The suction grasper 80 has anouter diameter slightly less than the inner diameter of the workingchannel of the A-frame device 10, so that the grasper 80 can be insertedinto the working channel of the A-frame device 10, as shown in FIG. 25.

FIGS. 26 and 27 are top and bottom views of the grasper head 85 showingvarious components of the grasper head 85. The top portion of eachfigure shows the grasper head 85 in the assembled configuration, and theremaining portions of each figure show the separate components. Thegrasper head 85 can be made of metal, such as stainless steel ortitanium, polymers, ceramics, or any other combination thereof. Inaddition, at least a portion of the grasper head 85 may be coated with apolymer or elastomer material to provide a softer contact between thetissue and the grasper head 85 and to enhance the grip of the grasperhead on the tissue.

The grasper head 85 includes a head 84, a jaw assembly 82, a translucentconcave insert 86 made of a polymer or glass, and a jaw operating device88. The head 84 has an opening 83 through which the tissue is grasped bysuction. FIGS. 27A-27D schematically illustrate various assemblyconnection stages of the jaw assembly for operation. The jaw assembly 82includes a pair of jaws 82 a, 82 b welded to a flexible spring set 82 cthat is biased open. The spring set 82 c has an opening 82 d, 82 e oneach end and is fixed to the grasper head 84 with a suitable fixingmeans, such as screws. The jaw operating device 88 includes a loop ofoperating cable 89. Each of the jaws 82 a, 82 b has a groove 82 f, 82 gmilled in its side portion, and the operating cable 89 passes betweenthe spring set 82 c and the groove 82 f, 82 g, as shown in FIG. 27D.During assembly, one end of the cable 89 is passed, in order, throughthe proximal opening 82 e of the spring set 82 c, through the groove 82f, 82 g of one of the jaws 82 a, 82 b, through the distal opening 82 dof the spring set 82 c, through the groove 82 f, 82 g of the other ofthe jaws 82 a, 82 b, and finally through the proximal opening 82 e ofthe spring set 82 c. Preferably, the operating cable 89 is twisted atits distal end after passing through the distal opening 82 d to form asmall loop 89 a at its distal end, so that the cable 89 is connected tothe opening 82 d with the crossed cable, as shown in FIG. 27C. Theproximal opening 82 e is connected to the cable 89 in similar manner.

In operation, pulling the loop of operating cable 89 (by handle 90 asdescribed below) causes the flexible spring set 82 c to deform into aU-shaped configuration, thereby causing the pair of jaws 82 a, 82 b toclose. The pair of jaws 82 a, 82 b are disposed in the close vicinity ofthe opening 83 to hold the tissue more tightly once suction has beenapplied. The concave insert 86 covers the back side of the grasper head84 to form a suitable vacuum inside the suction grasper head 85. Sincethe concave insert 86 is translucent, the process of grasping andholding of the tissue can be readily observed from an endoscope.

FIGS. 28 through 31 show the grasper handle 90 that connects to thegrasper shaft 87 to operate the grasper head 85. As shown in FIG. 28,the grasper shaft 87 is a single or multiple wound coil 91 covered witha heat shrink material 92. The grasper shaft 87 is rigid enough to pushthe grasped esophageal tissue into the stomach, yet flexible enough totraverse tortuous anatomy of a body. Alternatively, the grasper shaft 87can be any device known in the catheter art, including, but not limitedto, single or multiple extrusions, braid, or coil reinforcements andhypotubes.

The grasper handle 90 includes a base 94, a cover 96, and a jaw knob 98.The jaw knob 98 is mechanically coupled to a threaded shaft 97. Afollower 99 is inserted into the threaded shaft 97 so that, when thethreaded shaft 97 is rotated, the follower 99 can move axially along thethreaded portion of the threaded shaft 97. The loop of operating cable89 is crimped on the follower 99 by a pin 93 (see FIG. 31). The cover 96includes a tube fitting 95 through which a vacuum suction is provided,and the base 94 has a hollow bore in communication with the coil lumen87. Various sealing members, such as, for example, O-rings, rubberseals, etc., are used to seal off the vacuum path from the tube fitting95 to the grasper head 85.

In operation, a source of vacuum (not shown) is connected to the tubefitting 95 to create a desired amount suction in the grasper head 85,shown in FIGS. 26 and 27. The tissue is thereby sucked and held in theopening 83 of the grasper head 85. Once the tissue is properly held inthe opening 83, the jaw knob 98 is rotated to cause rotation of thethreaded shaft 97, which in turn moves the follower 99 in the directionaway from the grasper head 85. The movement of the follower 99 thenpulls the cables 89 and causes the jaws 82 a, 82 b to close and firmlygrasp the tissue held in the opening 83 by suction.

In alternative embodiments, other invagination devices having varioustissue securing means, such as, for example, clamps, forceps, hooks,suction cups or tubes, can be utilized.

Fastener Delivery System

With reference to FIGS. 32 through 36, a fastener delivery system,according to an embodiment of the present invention, is describedherein. The delivery system 100 includes a delivery guide 101, adelivery needle 120, and a pusher 125 as its main components. Thedelivery system 100 is used to deliver and deploy a tissue fastener tothe tissue layers to be fastened together.

The delivery guide 101 includes a driver head 110 connected to a conduit105 via a threaded transition piece 115, and a proximal handle 130. FIG.34 shows the construction of the driver head 110, according to anembodiment of the present invention. In this embodiment, the head 110 istwo interconnected pieces, shown in the bottom two figures in FIG. 34.The top figure of FIG. 34 is the assembled head 110. The 110 can be madeof metal, such as stainless steel or titanium, polymers, ceramics, orany other combination thereof. In addition, at least a portion of thehead 110 may be coated with a polymer or elastomer material to provide asofter contact with tissue.

The head 110 includes a fastener seat 112 formed on its top surface. Aswill be described further herein, a proximal member 201 a, 221, 231, 241of a fastener 200, 210, 220, 230, 240 is placed in the fastener seat 112for deployment. The shape of the fastener seat 112 may vary depending onthe type and shape of the fastener in use. As shown in the middle ofFIG. 34, the head 110 includes a threaded portion 116 for coupling withthe transition piece 115 of the conduit 105, and an internal groove 114with a desired predetermined deflection angle for passage of the needle120. Preferably, the head 110 may include an internal slot 118 forplacing a cutting member 212 to cut excess connecting member materialafter the fastener is deployed in place, as will be described furtherherein. Alternatively, the head 110 or the needle 120 may include acutting member to cut the excess connecting member material. The conduit105 may be a coiled lumen covered with a heat shrink material. As shownin FIG. 35, the proximal end of the conduit 105 is connected to a drivehandle 127. The drive handle 127 may include an elongated slot 124 tolimit axial and rotational motion of the needle 120 slidably insertedinside the lumen of the delivery guide 101, as will be described furtherherein.

Bottom two figures of FIG. 32 show a delivery needle 120 and a deliverypusher 125, according to an embodiment of the present invention. Asshown in FIG. 33, the needle 120 has a pre-curved distal end portion anda sharp beveled distal end 121 for perforating the folded tissue layersduring deployment of a tissue fastener. The delivery needle 120 is ahollow conduit that has an outer diameter smaller than the innerdiameter of the delivery guide lumen, and is thereby configured to slideinside the lumen relative to the delivery guide 101. The pusher 125 ispreferably flexible cable that has an outer diameter smaller than theinner diameter of the delivery needle 120, so that the pusher 125 can beslidably inserted into the needle 120. FIG. 33 show the distal portionof the needle 120 and the pusher 125, according to an embodiment of thepresent invention.

Bottom two figures of FIG. 35 show a needle driver 128 for the deliveryneedle 120 and a pusher driver 129 for the delivery pusher 125,according to an embodiment of the invention. The needle driver 128 is ahollow tube that includes a generally cylindrical distal portion 128 ahaving an outer diameter slightly less than the inner diameter of thedrive handle 127, and a generally cylindrical distal portion 128 bhaving an outer diameter greater than the inner diameter of the drivehandle 127. The distal portion 128 b thus limits the movement of theneedle 120 once inserted within the lumen of the drive guide 101 andprevents the needle 120 from falling into the lumen. The needle driver128 may also include a guide member 128 c protruding transversely withrespect to the outer surface of the needle driver 128. The guide member128 c is guided within the elongated slot 124 formed in the drive handle127 to limit the axial and rotational motion of the needle driver 128.

The pusher driver 129 may also include a distal portion 129 a having anouter diameter slightly less than the inner diameter of the needledriver 128, and a distal portion 129 b having an outer diameter greaterthan the inner diameter of the needle driver 128. Thus, the distalportion 129 b limits the movement of the pusher 125 once insertedthrough the needle 120 and prevents the pusher 129 from falling into thelumen of the needle 120. The pusher 125 may include means for grasping aportion of the fastener during deployment. The means for grasping may bea pair of jaws attached to the distal end of the pusher 125, or a pairof split ends at the end of the pusher 125 that are configured to hold afastener therebetween.

Tissue Fasteners

With reference to FIGS. 37A-37B and FIGS. 38A-38C, various embodimentsof a tissue fastener, according to the present invention, are describedherein. FIGS. 37A and 37B show double T-fasteners 200, 210 having aproximal member 201 a and a distal member 201 b each connected to aconnecting member 205, such as, for example, a suture, a bar, a coil, ora spring. The connecting member may be elastic to provide forself-adjustment. The fastener 200 shown in FIG. 37A has substantiallyidentical members 201 a, 201 b on both ends of the connecting member205. In an embodiment shown in FIG. 37B, the proximal member 211 on theesophageal side has a greater footprint than the distal member 201 onthe stomach side. This acts to distribute forces on a larger area of theesophageal tissue. The proximal member 211 may have a smooth outersurface profile to minimize traumatization to a patient.

FIGS. 38A-38C show adjustable tissue fasteners, according to variousembodiments of the present invention. The tissue fasteners 220, 230, 240shown in the figures have proximal members 221, 231, 241 with greaterfootprints than those of the distal members 201. Furthermore, while thedistal members 201 are fixedly attached to the distal end of theconnecting member (such as a connecting member 205), the proximalmembers 221, 231, 241 are axially movable along the length of theconnecting member 205, thereby allowing adjustment of the fasteningtension between the distal and proximal members. Detailed descriptionsof these embodiments are presented along with methods of fasteningtissue layers further herein. Other various embodiments of a tissuefastener, such as the embodiments described in the commonly assignedU.S. application Ser. No. 10/230,672 of Robert DeVries et al.(Application Publication No. US-2004-0044364-A1), the disclosure ofwhich is hereby incorporated by reference, may alternatively beutilized.

Steps of Procedure

With reference to FIGS. 39 through 46, an exemplary method ofendoluminal fundoplication, according to an embodiment of the presentinvention, is described herein. FIG. 39 schematically illustrates thetransoral insertion of the A-frame device 10 into the esophagus 3.During the insertion, protective sleeve 62 is provided to cover theA-frame head 20. Preferably, a suitable lubrication material is appliedon the outer surface of the protective sleeve 62. The protective sleeve62 protects the esophageal wall 4 from possible damage during theinsertion. The protective sleeve 62 has an opening in its distal end foran endoscope 250 to protrude out of the sleeve 62 for viewing. It shouldbe understood that other types of protective sleeves, such as, forexample, embodiments shown in FIGS. 22 and 23, can be alternativelyutilized.

As shown in FIG. 40, once the A-frame head 20 is safely inserted intothe gastro-esophageal junction site, the protective sleeve 62 iswithdrawn from the A-frame head 20 through a working channel of theA-frame device 10. This may be achieved by pulling the handle of theprotective sleeve 62 proximally, causing the sleeve 62 to invert andmove into the working channel where it is withdrawn. The endoscope 250is then retroflexed in the stomach 7 to view the A-frame head 20 and theworking area. Once the A-frame head 20 is positioned in the stomach, thefolding arm 25 of the A-frame head 20 is opened by using the A-framehandle 30 on the proximal end of the downtube 15, as shown in FIG. 41.The folding arm 25 extends in the stomach 7. The A-frame head then isproperly positioned within the esophagus above the gastroesophagealjunction.

As shown in FIG. 42, when the A-frame head 20 is properly positionedwith the folding arm opened, and the esophageal and fundus walls 4, 6are ready to be folded, an invagination device, such as, for example, agrasper 85, is advanced into the A-frame overtube 15 and positionedproximate to the esophageal wall 4. A vacuum source (not shown) is thenturned on and the suction force firmly grasps the esophageal wall 4, asshown in FIG. 43. The grasping of the esophageal wall 4 may be enhancedby activation of jaws 82 a, 82 b that may be placed in the vicinity ofthe suction opening 83 for holding the wall 4 more tightly when thesuction is applied.

The firmly grasped esophageal wall 4 is then pushed down into thestomach 7 before the fundus wall of the stomach is folded proximate tothe esophageal wall 4, as shown in FIG. 44. The folding arm 25 thencloses and folds the fundus wall 6 proximate to the esophagus wall 4,creating a plicated fold 1, as shown in FIG. 45. While the folding arm25 firmly holds the plicated fold 1, the vacuum from the grasper 85 andthe grasp by the jaws 82 a, 82 b are released. The grasper 85, togetherwith the jaws 82 a, 82 b, is then withdrawn from the A-frame head 20.

A method of fastening a plicated fold 1 with a tissue fastener,according to an embodiment of the present invention, is described hereinwith reference to FIGS. 46-47. After creating a plicated fold 1 at thegastro-esophageal junction, a fastener delivery system 100, shown inFIGS. 32-36, is inserted into the working channel of the A-frame head20. Prior to insertion into the A-frame device, the proximal member 201a of the tissue fastener 200 is placed on a fastener seat 112 formed onthe outer top surface of the head 110 and the distal member 201 b isplaced inside the distal end portion of the needle 120.

As shown in FIG. 46, the delivery system 100 containing the doubleT-fastener 200 is advanced into the A-frame head 20 and placed proximateto the plicated fold 1, held by the folding arm 25. The needle 120having a sharp cutting edge 121 is then guided along the internal groove114 formed in the head 110 and perforates through the plicated fold 1,as shown in FIG. 46. Once the needle 120 passes through the plicatedfold 1, the pusher 125 pushes the distal member 201 b slight furtherinto the stomach side, so that distal member 201 b can extend out of theneedle lumen and anchor against the fundus wall 6. Since the distalmember 201 b is fixedly attached to the distal end of the connectingmember 205 with a predetermined length, the proximal member 201 a fallsout of the fastener seat 112 and anchors against the esophageal sidewall 4, as shown in the right figure of FIG. 46. Depending on, amongother things, the type of tissue fasteners used and the desiredfastening strength, additional tissue fasteners 200 may be placed byrepeating the method described above. In general, the entire A-framedevice 10 is rotatable and axially displaceable within the esophagus forplacing another fastener. In addition, only the fastener delivery systemcan be moved relative to the A-frame device 10. FIG. 47 shows thegastro-esophageal junction with a plurality of double T-fasteners 200 inplace. In this embodiment, the connecting member 205 has a predeterminedfixed length.

FIGS. 48-50 schematically illustrate a method of fastening the plicatedfold 1 with a tissue fastener 220, according to another embodiment ofthe present invention. Similar to the embodiment shown in FIGS. 46-47,prior to insertion into the A-frame device 10, the proximal member 221of the tissue fastener 220 is placed on a fastener seat 112 formed onthe outer top surface of the head 110 and the distal member 201 isplaced inside distal end portion of the needle 120. Preferably, thedistal member 201 has interference fit with the inner surface of theneedle 120 so that the distal member 201 does not fall out of the needle120. Alternatively, the pusher 125 has a grasping means at its distalend to hold the distal member 201.

The operational procedures are substantially identical with the methodillustrated in FIGS. 46-47, except that the this procedure involves anadjustable fastener and that the proximal member of the fastener has agreater footprint than that of the distal member. For example, while thedistal member 201 is fixedly secured to a distal end of the connectingmember 205, the proximal member 221 is axially movable along the lengthof the connecting member 205 and, thereby, the fastening tension can beadjusted. The connecting member 205 may extend outside of a body orconnects to a suitable grasper-pusher device that extends outside of thebody. Preferably, the proximal member 221 is movable only in a directiontoward the distal member 201.

As shown in FIG. 48, once the needle 120 and the tissue fastener 220 arebrought proximate to the plicated fold 1, the needle 120 perforatesthrough the plicated fold 1, carrying the distal member 201 of thefastener 220 into the stomach side 7. After the distal member 201 fallsinto the stomach side 7, the proximal member 221 falls out of thefastener seat 112 and loosely faces against the esophageal side wall 4,as shown in the right figure of FIG. 48. The proximal end 205 a of theconnecting member 205 is then pulled back to tighten the tension betweenthe distal and proximal members 221, 201 of the fastener, as shown inthe right-hand portion of FIG. 49.

After the tension is adjusted as desired, any excess connecting member205 a beyond the proximal member 221 is cut by a blade member 212disposed in an internal slot 118 formed in the head 110. In thisembodiment, the blade member 212 has an eye-shaped opening 214 throughwhich the connecting member 205 passes behind the proximal member 212.Preferably, prior to the insertion of the delivery system 200 in theA-frame device 10, the blade member 212 is placed in the internal slot118, and the proximal member 221 of the fastener 220 is placed in thefastener seat 112 with the connecting member 205 behind the proximalmember 221 passing through the opening 214 of the blade member 212, asshown in FIG. 49. At least a portion of the opening peripheral edge hasa sharpened edge for cutting the excess connecting member 205 a.Activation of the blade member 212 can be achieved by any suitableproximal activation device attached to the blade member 212 by a wire,cable, or other like mechanisms 212 a. FIG. 50 shows thegastro-esophageal junction with a plurality of button fasteners 220 inplace.

FIG. 51 shows the gastro-esophageal junction with a plurality ofdome-shaped button fasteners 230 in place, according to still anotherembodiment of the present invention. The dome-shaped button fastener 230provides enhanced buttressing effect. This fastener 230 is alsotension-adjustable and includes a tab 235 to adjust the tension of theconnecting member 205. Preferably, the tab 235 rests on the proximalmember 231 of the faster 230 and is closes the opening 236 in theproximal member 231, through which the connecting member 205 passes.Thus, once the connecting member 205 is pulled, the tab 235 slightlyopens the opening. Once the desired tension is achieved, the connectingmember 205 is released and the tab 235 secures the movement of theproximal member 231 relative to the connecting member. Alternatively,the connecting member 205 may include other suitable friction means,such as, for example, bumps and notches, that is configured to interferewith the tab 235 and allow displacement in only one direction,preferably to the proximal side (see arrow in FIG. 51).

FIG. 52 shows the gastro-esophageal junction with a plurality of buttonfasteners 240 in place, according to yet another embodiment of thepresent invention. The proximal member 241 of the fastener 240 has firstand second openings 243, 246 with a slot 244 communicating between thetwo openings 243, 246. The connecting member 205 includes a plurality ofknots 205 b, each separated preferably with an uniform interval, thoughknots 205 b can be separated by any desired uniform or non-uniforminterval. The area of the first opening 243 is large enough to allow theknots 205 b to freely pass through the opening 243, while the area ofthe second opening 245 is smaller than the outer diameter of the knots205 b so as not to allow the passage of the knots 205 b through theopening 245. The opening of the slot is only slightly larger than thediameter of the connecting member 205. In operation, the connectingmember 205 having a plurality of knots 205 b is positioned in the firstopening 243 and adjusted to achieve a desired level of tension betweenthe distal and proximal members 201, 241 in the connecting member 205.Once the desired tension is achieved, the connecting member 205 istransferred to the second opening 246 to hold the corresponding knot 205b against the proximal member 241.

Other suitable designs of tissue fasteners having the similaroperational characteristics may be utilized. Moreover, the disclosedtissue fasteners 200, 210, 220, 230, 240 may be used with any othersuitable deployment mechanisms known in the art.

Although the present invention is depicted in this disclosure as beingused in the treatment of GERD, e.g., a fundoplication procedureperformed in the gastro-esophageal junction, it is to be understood thatthe tissue fastener and related deployment methods and systems of thepresent invention can be used to treat any of a number of differentdisease conditions, and can be used for fastening any desired bodytissues.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-6. (canceled)
 7. A protective device configured to receive anendoscopic device, comprising: an elongate body having a distal end anda proximal end; a distal opening located distally on the elongate body;a proximal opening located proximally on the elongate body and having aninner diameter larger than an inner diameter of the distal opening; anda lumen extending from the distal opening to the proximal opening,wherein the lumen is configured to receive the endoscopic device.
 8. Theprotective device of claim 7, wherein the distal opening is located atthe distal-most end of the elongate body and the proximal opening islocated at the proximal-most end of the elongate body.
 9. The protectivedevice of claim 7, wherein the elongate body includes a tapered sectionlocated distally on the elongate body.
 10. The protective device ofclaim 7, wherein the elongate body includes a translucent material. 11.The protective device of claim 7, further including a handle coupled tothe elongate body.
 12. The protective device of claim 11, wherein thehandle is flexible to traverse a tortuous anatomical lumen of a humanbody.
 13. The protective device of claim 11, wherein the handle includesa tube.
 14. The protective device of claim 11, wherein the handle isconfigured to fit within and translate relative to a working channel ofthe endoscopic device.
 15. The protective device of claim 7, wherein awall thickness of a distal portion of the elongate body is greater thana wall thickness of a proximal portion of the elongate body.
 16. Theprotective device of claim 7, further including the endoscopic device.17. A protective device configured to receive an endoscopic device,comprising: an elongate body having a distal end and a proximal end,wherein the elongate body includes an inflatable portion configured toexpand at least part of the elongate body, a distal opening, and aproximal opening having an inner diameter larger than an inner diameterof the distal opening; and a lumen extending from the distal opening tothe proximal opening, wherein the lumen is configured to receive theendoscopic device.
 18. The protective device of claim 17, wherein theinflatable portion is configured to expand an outer diameter of theelongate body.
 19. The protective device of claim 17, wherein theinflatable portion is configured to contract an inner diameter of thelumen.
 20. The protective device of claim 17, further including afluid-supplying member fluidly connected to the inflatable portion. 21.The protective device of claim 20, wherein the fluid-supplying memberincludes a connector.
 22. A method of manipulating a tissue within apatient, comprising: passing a protective device through a body lumen ofthe patient, the protective device having a lumen configured to receivean endoscopic device; locating at least part of the endoscopic devicewithin the lumen; passing an instrument through the endoscopic device;and manipulating the tissue of the patient with the instrument.
 23. Themethod of claim 22, further including at least partially inflating theprotective device.
 24. The method of claim 23, further includingexpanding an outer diameter of the protective device and contracting aninner diameter of the lumen.
 25. The method of claim 22, wherein thelocating step occurs prior to passing the protective device through thebody lumen.
 26. The method of claim 23, further comprising: at leastpartially deflating the protective device; withdrawing the endoscopicdevice from within the lumen; and withdrawing the protective device fromthe body lumen.